PMID- 18332471
OWN - NLM
STAT- MEDLINE
DCOM- 20080429
LR  - 20220316
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 26
IP  - 12
DP  - 2008 Apr 20
TI  - Letrozole compared with tamoxifen for elderly patients with endocrine-responsive 
      early breast cancer: the BIG 1-98 trial.
PG  - 1972-9
LID - 10.1200/JCO.2007.14.0459 [doi]
AB  - PURPOSE: To explore potential differences in efficacy, treatment completion, and 
      adverse events (AEs) in elderly women receiving adjuvant tamoxifen or letrozole 
      for five years in the Breast International Group (BIG) 1-98 trial. METHODS: This 
      report includes the 4,922 patients allocated to 5 years of letrozole or tamoxifen 
      in the BIG 1-98 trial. The median follow-up was 40.4 months. Subpopulation 
      Treatment Effect Pattern Plot (STEPP) analysis was used to examine the patterns 
      of differences in disease-free survival and incidences of AEs according to age. 
      In addition, three categoric age groups were defined: "younger postmenopausal" 
      patients were younger than 65 years (n = 3,127), "older" patients were 65 to 74 
      years old (n = 1,500), and "elderly" patients were 75 years of age or older (n = 
      295). RESULTS: Efficacy results for subpopulations defined by age were similar to 
      the overall trial results: Letrozole significantly improved disease-free survival 
      (DFS), the primary end point, compared with tamoxifen. Elderly patients were less 
      likely to complete trial treatment, but at rates that were similar in the two 
      treatment groups. The incidence of bone fractures, observed more often in the 
      letrozole group, did not differ by age. In elderly patients, letrozole had a 
      significantly higher incidence of any grade 3 to 5 protocol-specified 
      non-fracture AE compared with tamoxifen (P = .002), but differences were not 
      significant for thromboembolic or cardiac AEs. CONCLUSION: Adjuvant treatment 
      with letrozole had superior efficacy (DFS) compared with tamoxifen in all age 
      groups. On the basis of a small number of patients older than 75 years (6%), age 
      per se should not unduly affect the choice of adjuvant endocrine therapy.
FAU - Crivellari, Diana
AU  - Crivellari D
AD  - IBCSG Coordinating Center, Effingerstrasse 40, CH-3008 Bern, Switzerland. 
      dcrivellari@cro.it
FAU - Sun, Zhuoxin
AU  - Sun Z
FAU - Coates, Alan S
AU  - Coates AS
FAU - Price, Karen N
AU  - Price KN
FAU - Thurlimann, Beat
AU  - Thurlimann B
FAU - Mouridsen, Henning
AU  - Mouridsen H
FAU - Mauriac, Louis
AU  - Mauriac L
FAU - Forbes, John F
AU  - Forbes JF
FAU - Paridaens, Robert J
AU  - Paridaens RJ
FAU - Castiglione-Gertsch, Monica
AU  - Castiglione-Gertsch M
FAU - Gelber, Richard D
AU  - Gelber RD
FAU - Colleoni, Marco
AU  - Colleoni M
FAU - Lang, Istvan
AU  - Lang I
FAU - Del Mastro, Lucia
AU  - Del Mastro L
FAU - Gladieff, Laurence
AU  - Gladieff L
FAU - Rabaglio, Manuela
AU  - Rabaglio M
FAU - Smith, Ian E
AU  - Smith IE
FAU - Chirgwin, Jacquie H
AU  - Chirgwin JH
FAU - Goldhirsch, Aron
AU  - Goldhirsch A
LA  - eng
GR  - U24 CA075362/CA/NCI NIH HHS/United States
GR  - CA-75362/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20080310
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Nitriles)
RN  - 0 (Triazoles)
RN  - 094ZI81Y45 (Tamoxifen)
RN  - 7LKK855W8I (Letrozole)
SB  - IM
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Antineoplastic Agents, Hormonal/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy
MH  - Cardiovascular Diseases/chemically induced
MH  - Double-Blind Method
MH  - Female
MH  - Fractures, Bone/chemically induced
MH  - Humans
MH  - Letrozole
MH  - Middle Aged
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Patient Compliance
MH  - Postmenopause
MH  - Tamoxifen/adverse effects/*therapeutic use
MH  - Triazoles/adverse effects/*therapeutic use
EDAT- 2008/03/12 09:00
MHDA- 2008/04/30 09:00
CRDT- 2008/03/12 09:00
PHST- 2008/03/12 09:00 [pubmed]
PHST- 2008/04/30 09:00 [medline]
PHST- 2008/03/12 09:00 [entrez]
AID - JCO.2007.14.0459 [pii]
AID - 10.1200/JCO.2007.14.0459 [doi]
PST - ppublish
SO  - J Clin Oncol. 2008 Apr 20;26(12):1972-9. doi: 10.1200/JCO.2007.14.0459. Epub 2008 
      Mar 10.